Microsoft word - vetmedin 2.5 mg.doc

DIN 02248158

PrVetmedin® 2.5 mg capsules for dogs 2.5 mg pimobendan per capsule Net Contents: 100 capsules Veterinary Use Only Description Pimobendan, a benzimidazole-pyridazinone derivative, is a non-sympathomimetic, non-glycoside inotropic substance with potent vasodilatative properties. Pharmacology Pimobendan exerts its stimulatory myocardial effect by a dual mechanism of action: increase in calcium sensitivity of cardiac myofilaments and inhibition of phosphodiesterase (type III). It also exhibits a vasodilating action through an inhibitory action on phosphodiesterase III activity. Following oral administration of Vetmedin® capsules, the absolute bioavailability of the active principle is 60–63%. Mean plasma protein binding is 93%. The plasma elimination half-life of pimobendan is approximately 30 minutes and the main active metabolite elimination half-life is approximately 2 hours. Almost the entire dose is eliminated via feces. The tolerance of pimobendan has been evaluated in pre-clinical studies in healthy Beagle dogs with nondiseased hearts. Daily intravenous administration of pimobendan at dosages of 0.5 mg/kg to 8.0 mg/kg over a period of 2 to 4 weeks was associated with exaggerated myocardial contractility and jet lesions to the myocardium. These intravenous dosages are equivalent to one-time oral dosages of 0.8 mg/kg to 12.8 mg/kg. Lesions were not seen at intravenous dosages of 0.25 mg/kg (equivalent to 0.4 mg/kg orally) administered over a 2 to 4 week period. Indications: Dogs For the treatment of congestive heart failure originating from dilated cardiomyopathy or valvular insufficiency. It is recommended that the diagnosis of congestive heart failure be confirmed by radiographs or diuretic responsiveness. Treatment should be initiated only in symptomatic cases which will benefit from increased myocardial contractility (positive inotropy). Dosage and administration Vetmedin® capsules should be administered orally at a dose range of 0.2 mg to 0.6 mg pimobendan/kg body weight per day. The preferable daily dose is 0.5 mg pimobendan/kg body weight. The dose should be divided into two administrations (0.25 mg/kg each), one half of the dose in the morning and the other half approximately 12 hours later. Each dose should be given approximately one hour before feeding. Vetmedin® capsules may be combined with a diuretic treatment such as furosemide. Caution Atrial fibrillation occurs commonly in cases of congestive heart failure and indicates a more guarded prognosis. According to good veterinary practice, dogs with congestive heart failure should be monitored for presence of arrhythmias during cardiac therapy. Appropriate anti-arrhythmic should be initiated if indicated. Contra-indications Vetmedin® capsules should not be used in cases of hypertrophic cardiomyopathies or clinical conditions where an augmentation of cardiac output is not possible for functional or anatomical reasons (e.g. aortic stenosis). Use during pregnancy and lactation In studies with rats and rabbits, pimobendan had no effect on fertility and embryotoxic effects only occurred in maternotoxic doses. In rat experiments it has been shown that pimobendan is excreted into milk. Therefore, Vetmedin® capsules should only be administered to pregnant and lactating bitches if the expected therapeutic benefits overweigh the potential risk. Drug Interactions There is always a risk of drug interactions when using multiple medications in a compromised or geriatric patient. Use with caution with other positive inotropes. As pimobendan is highly protein bound, monitor carefully if using other drugs with high protein binding. Concurrent use of beta blockers or calcium-channel blockers may decrease pimobendan-induced effects on myocardial contractility. Side Effects Pimobendan administered as an overdose orally may result in profuse vomiting. Patients should be treated symptomatically. The following suspected adverse effects have been reported following clinical use. Cardiovascular: Tachycardia (may be dose dependent and avoided by reducing the dose). Gastrointestinal: Vomiting, diarrhea, inappetence. Nervous system/Behavioural: Uneasiness, incoordination, convulsions. Renal: Polyuria, polydypsia. Warning: KEEP OUT OF REACH OF CHILDREN. If poisoning occurs, contact a doctor or Poisons Information Center. Storage: Store below 25°C. Keep the container tightly closed. Presentations Vetmedin® 1.25 mg capsule contains 1.25 mg pimobendan. Vetmedin® 2.5 mg capsule contains 2.5 mg pimobendan. Vetmedin® 5.0 mg capsule contains 5.0 mg pimobendan. Boehringer Ingelheim (Canada) Ltd. Burlington, Ontario L7L 5H4 Black 60004058/CA/1